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The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning for acute ischemic stroke.
In this study, 2210 cases of ischemic stroke in 72 hours were included in 10 centers in China according to the principle of random, and parallel control. The experimental group receive basic treatment and remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days. The control group receive basic treatment and remote ischemic conditioning control for 60mmHg, 2 times per day for 7 consecutive days. Two groups will be followed up for 90 days to evaluate the efficacy and safety of remote ischemic conditioning in treating acute ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIC+Standard medical treatment | Active Comparator | Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 consecutive days. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014. |
|
| Sham RIC+Standard medical treatment | Placebo Comparator | Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 consecutive days. Additionally, the patients will be treated with standard medical treatment according to the Guidelines for diagnosis and treatment of acute ischemic stroke in China 2014. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning | Procedure | Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with modified Rankin Scale (mRS) Score 0-2. | Proportion of patients with modified Rankin Scale (mRS) Score 0-2. Ranged from 0 to 6, a low value represents a better outcome. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| National Institute of Health stroke scale (NIHSS) at 7 days, 30±3 days, 90±3 days from onset. | National Institute of Health stroke scale (NIHSS) at 24 hours, 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 42, a low value represents a better outcome. | 7days, 30±3 days, 90±3 days |
| modified Rankin Scale (mRS) Score at 7 days, 30±3 days, 90±3 days from onset. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days. | Blood pressure at 24 hours, 7 days, 30±3 days, 90±3 days. | 24 hours, 7 days, 30±3 days, 90±3 days |
| heart rate at 24 hours, 7 days, 30±3 days, 90±3 days. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Yang, MD, PhD | Contact | 0086-13756661217 | doctor_yangyi@163.com | |
| Zhenni Guo, MD, PhD | Contact | zhen1ni2@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Sham remote ischemic conditioning | Procedure | Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg. |
|
modified Rankin Scale (mRS) at 24 hours, 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 6, a low value represents a better outcome. |
| 7days, 30±3 days, 90±3 days |
| Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset. | Barthel Index (BI) at 7 days, 30±3 days, 90±3 days from onset. Ranged from 0 to 100, a high value represents a better outcome. | 7days, 30±3 days, 90±3 days |
| Proportion of patients with hemorrhagic transformation during hospitalization. | Proportion of patients with hemorrhagic transformation during hospitalization. | 7 days |
| Frequency of adverse events during follow-up. | Severe adverse events through day-90 after the onset of acute ischemic stroke. | 90 days |
heart rate at 24 hours, 7 days, 30±3 days, 90±3 days.
| 24 hours, 7 days, 30±3 days, 90±3 days |
| Numeric rating scales (NRS) score during intervention. | Numeric rating scales (NRS) score during intervention. Ranged from 0 to 10, a low value represents a less pain. | 7 days |
| Proportion of patients with early withdrawal for safety or tolerability reasons. | Proportion of patients with early withdrawal for safety or tolerability reasons. | 7 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |